BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 170924 · Received June 4, 1998

    Report

    Report Number
    2953200-1998-00083
    Event Type
    Injury
    Date Received
    June 4, 1998
    Date of Event
    May 6, 1998
    Report Date
    May 6, 1998
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING, INC.
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.0MM DIAMETER X 18MM LENGTH AVE GFX STENT WAS SUCCESSFULLY PLACED AT THE TARGET LESION IN THE DISTAL ANTERIOR DESCENDING CORONARY ARTERY. IN ADDITION, THREE 3.5MM DIAMETER X 18MM LENGTH AVE GFX STENT WERE DEPLOYED PROXIMAL TO THE 3.0MM X 18MM STENT IN AN OVERLAPPING FASHION, WHICH COVERED THE MID-DISTAL PORTION OF THE TARGET VESSEL. ALL OF THE AVE STENTS WERE THE MID-DISTAL PORTION OF THE TARGET VESSEL. ALL OF THE AVE STENTS WERE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY BALLOON. AFTER REMOVAL OF THE POST-DILATATION PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY BALLOON, ANGIOGRAPHY REVEALED EVIDENCE OF "NO REFLOW" PHENOMENON. THE PHYSICIAN WAS CONCERNED THAT THERE MIGHT BE A DISSECTION LOCATED PROXIMAL TO THE MOST PROXIMAL GFX STENT AND DEPLOYED ANOTHER MFR'S STENT, PARTIALLY OVERLAPPING THE GFX STENT. THIS RESULTED IN PERSISTENCE OF THE "NO REFLOW" PHENOMENON AND PROPAGATION OF THE INTRACORONARY THROMBUS IN THE PROXIMAL TWO STENTS. SUBSEQUENTLY, A 3.5MM DIAMETER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PERFUSION BALLOON WAS USED TO POST-DILATE THE PROXIMAL PORTION OF THE STENTED SEGMENT, WITH FAIR RESULTS. ANOTHER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY BALLOON, 3.0MM DIAMETER X 40MM LENGTH, WAS USED TO POST-DILATE THE REMAINDER OF THE STENTED AREA IN THE TARGET VESSEL. THE DR FELT, THEN, THAT THERE MIGHT BE A DISSECTION BETWEEN THE THIRD AND FOURTH GFX STENTS TO COVER THE QUESTIONABLE DISSECTION WITH FAIR RESULTS. THERE WAS SOME MINOR IMPROVEMENT IN ANTEGRADE FLOW, SUGGESTING SEVERE "NO REFLOW" PHENOMENON AS ETIOLOGY. THE INTERVENTIONAL PROCEDURE WAS TERMINATED, AT THIS POINT, AND AN INTRA-AORTIC BALLOON PUMP WAS PLACED. THE PT WAS COMPLAINING OF MINOR CHEST DISCOMFORT AND HAD NO ARRHYTHMIAS. FIVE DAYS LATER, THE PT WAS DISCHARGED TO HOME AND THERE WAS NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT. MEDWATCH FORMS HAVE BEEN FILED SEPARATELY FOR EACH OF THE FOUR AVE DEVICES INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVE GFX OTW CORONARY STENT SYSTEM Implant OVER-THE-WIRE CORONARY STENT SYSTEM MAF ARTERIAL VASCULAR ENGINEERING, INC. NA 8D22ED9

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention VERSAD, MORPHINE, NUBAIN, REOPRO, HEPARIN(11,500U)| DURING THE PROCEDURE THE PT WAS GIVEN VARAPAMIL,| NITROGLYCERIN, AND UROKINASE.